Hybrid Senior Data Scientist — CPV & APQR Reporting

Spectraforce Technologies, Inc.

Madison (NJ)

Hybrid

USD 120,000 - 180,000

Full time

4 days ago
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Job summary

Spectraforce Technologies, Inc. is seeking a Senior Scientist, Data Science and Reporting for the CPV and APQR programs in our Madison, NJ site.

The role focuses on monitoring production and release testing data, trending CPV parameters, and configuring analytic platforms to support the cell therapy network. You will collaborate with Global MSAT, Manufacturing, Quality, and Supply Chain to ensure on-time reporting and continuous process improvement, leveraging R/JMP/SAS for multivariate analyses

Qualifications

  • Proficiency in statistical tools and data-driven decision making.
  • Experience with R, JMP, MINITAB, or SAS; JMP preferred.
  • Detail oriented with strong time management to meet timelines.
  • Strong communication with cross-functional teams.
  • Expert knowledge of cGMPs and multinational biopharma regulations.
  • Experience in CPV and APQR reporting preferred.

Responsibilities

  • Maintain SPC program and manufacturing performance trending.
  • Provide multivariate analysis for process understanding.
  • Monitor CPV parameters and alert on SAEs.
  • Support investigations with data and analysis.
  • Meet CPV and APQR timelines.
  • Author and review CPV/APQR documents.
  • Collaborate with MSAT, QA, Supply Chain, and Manufacturing.
  • Stay updated with industry trends and best practices.
  • Identify Opex opportunities through data-driven evaluation.

Skills

Statistical analysis
R
JMP
MINITAB
SAS
Data visualization
cGMP knowledge
CPV/APQR

Education

Bachelor's degree in science or engineering
Graduate degree preferred

Tools

JMP
SAS
MINITAB
R

Job description

Spectraforce Technologies, Inc. is seeking a Senior Scientist, Data Science and Reporting for the CPV and APQR programs in our Madison, NJ site.

The role focuses on monitoring production and release testing data, trending CPV parameters, and configuring analytic platforms to support the cell therapy network. You will collaborate with Global MSAT, Manufacturing, Quality, and Supply Chain to ensure on-time reporting and continuous process improvement, leveraging R/JMP/SAS for multivariate analyses

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